A Multicenter Randomised Phase II Study Comparing the Efficiency of a HT Concomitant With RT vs RT Alone in the Salvage of Patients With a Detectable PSA After Prostatectomy
Overview
- Phase
- Phase 2
- Intervention
- Pelvic Radiotherapy
- Conditions
- Adenocarcinoma of Prostate
- Sponsor
- UNICANCER
- Enrollment
- 120
- Locations
- 39
- Primary Endpoint
- The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.
Detailed Description
Study the effectiveness of the association of a short duration hormonal therapy by degarelix (Firmagon ®) and radiotherapy, with radiotherapy alone on survival without events in the treatment of detectable PSA after radical prostatectomy. 122 patients should be included over a period of 2 years. Patients will be treated according to the following scheme: * Arm A (61 patients) : Pelvic Radiotherapy: 46 Gy and prostate only boost up to 66 Gy * Arm B (61 patients) : Arm A + hormonal therapy by degarelix during 6 months
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient with localized prostate adenocarcinoma treated with radical prostatectomy (whatever the initial prognostic stage)
- •Post prostatectomy PSA ≥0.2 ng/mL measured between 1 month and 4 months after surgery and increasing to a second test performed between 1 et 8 months after the post prostatectomy dosage
- •PSA ≤2 ng/mL at moment of the randomisation
- •No clinical signs of progressive disease (bone scan or PET scan or abdominal and pelvic scan or MRI): N0, M0
- •Neutrophils ≥1500/mm³; platelet count ≥100 000/mm³
- •Bilirubin ≤ upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) ≤1.5 ULN
- •Creatinine \<140 µmol/L (or clearance \>60 mL/min)
- •Normal fasting glucose
- •Eastern Cooperative Oncology Group (ECOG) ≤1
- •Age \>18 years
Exclusion Criteria
- •Prostate cancer histology other than adenocarcinoma
- •Patients pN1, N1 and M1
- •History of pelvic radiotherapy
- •Contraindication to pelvic irradiation (eg, scleroderma, chronic inflammatory bowel disease, etc.)
- •Testosterone ≤0.5 ng/mL
- •History of surgical castration
- •Previous treatment by hormonotherapy
- •Antineoplastic treatment in progress
- •History of another invasive cancer within 5 years before inclusion (with the exception of a basal cell skin carcinoma treated)
- •Known pituitary adenoma
Arms & Interventions
Radiation
Pelvic radiotherapy * 46 Gy in 23 fractions of 2 Gy. * prostate only-boost up to 66 Gy
Intervention: Pelvic Radiotherapy
Radiation and Degarelix
Radiotherapy: * 46 Gy in 23 fractions of 2 Gy. * prostate only-boost up to 66 Gy Associated with hormonal therapy by degarelix: * beginning in parallel to radiotherapy for 6 months * First dose of 240 mg * Maintenance dose of 80 mg
Intervention: Degarelix
Radiation and Degarelix
Radiotherapy: * 46 Gy in 23 fractions of 2 Gy. * prostate only-boost up to 66 Gy Associated with hormonal therapy by degarelix: * beginning in parallel to radiotherapy for 6 months * First dose of 240 mg * Maintenance dose of 80 mg
Intervention: Pelvic Radiotherapy
Outcomes
Primary Outcomes
The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival
Time Frame: 5 years
Secondary Outcomes
- Survival without clinical event(5 years)
- kinetics of testosterone(up to 12 months after the end of the radiotherapy and after biological release)
- Overall survival(5 years)
- Patient Quality of life(up to 5 years after the end of the radiotherapy)
- Acute and late toxicities of the association of hormone therapy with radiotherapy(up to 5 years)
- Toxicities of radiotherapy(up to 5 years)
- Survival without biological event(5 years)
- Survival without metastases(5 years)